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Development and Validation of an LC-MS/MS Method for Simultaneous Determination of Canagliflozin and Metformin HCl in Rat Plasma and its Application

[ Vol. 16 , Issue. 6 ]

Author(s):

Vivek Nalawade*, Vaibhav A. Dixit, Amisha Vora and Himashu Zade   Pages 752 - 762 ( 11 )

Abstract:


Background: Food and herbal extracts rich in Quercetin (QRT) are often self-medicated by diabetics and can potentially alter the pharmacokinetics (PK) of Metformin HCl (MET) and Canagliflozin (CNG) leading to food or herb-drug interactions and reduced therapeutic efficacy. However, the impact of these flavonoids on the pharmacokinetic behaviour of MET and CNG is mostly unknown.

Methods: A simple one-step protein precipitation method was developed for the determination of MET and CNG from rat plasma. The mobile phase chosen was MeOH 65% and 35% water containing 0.1% formic acid at a flow rate of 1mL/min.

Results: The retention time of MET, internal standard (Valsartan) and CNG was 1.83, 6.2 and 8.2 min, respectively. The method was found to be linear in the range of 200 - 8000 ng/mL for CNG and 100 = 4000 ng/ml for MET. Precision and accuracy of the method were below 20% at LLOQ and below 15% for LQC, MQC, and HQC.

Conclusion: The method was successfully applied for the determination of PK of MET and CNG by using 100 μL of rat plasma. QRT co-administration affects the PK parameters of MET and CNG. This alteration in PK parameters might be of significant use for clinicians and patients.

Keywords:

Pharmacokinetics, validation, quercetin, canagliflozin, metformin HCl, LC-MS/MS.

Affiliation:

SVKM’s, NMIMS Deemed to be University, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai, Maharashtra, Department of Pharmacy, Birla Institute of Technology and Sciences Pilani (BITSPilani), VidyaVihar Campus, street number 41, Pilani, 333031, Rajasthan, SVKM’s, NMIMS Deemed to be University, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai, Maharashtra, SVKM’s, NMIMS Deemed to be University, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai, Maharashtra

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